Evidence map›Paper›PMID 28120270›Full record

ArticleDrug safety2017

Feasibility and Educational Value of a Student-Run Pharmacovigilance Programme: A Prospective Cohort Study.

Tim Schutte, Jelle Tichelaar, Michael O Reumerman, Rike van Eekeren, Leàn Rolfes, Eugène P van Puijenbroek, Milan C Richir, Michiel A van Agtmael

Abstract read
In one paragraph

Article in Drug safety, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Tim SchutteDepartment of Internal Medicine, Pharmacotherapy Section, VU University Medical Center, Room ZH4A50, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands. t.schutte@vumc.nl.
Jelle TichelaarDepartment of Internal Medicine, Pharmacotherapy Section, VU University Medical Center, Room ZH4A50, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.
Michael O ReumermanDepartment of Internal Medicine, Pharmacotherapy Section, VU University Medical Center, Room ZH4A50, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.
Rike van EekerenThe Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Leàn RolfesThe Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Eugène P van PuijenbroekThe Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Milan C RichirDepartment of Internal Medicine, Pharmacotherapy Section, VU University Medical Center, Room ZH4A50, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.
Michiel A van AgtmaelDepartment of Internal Medicine, Pharmacotherapy Section, VU University Medical Center, Room ZH4A50, De Boelelaan 1117, 1081 HZ, Amsterdam, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionPharmacovigilance, the monitoring of drug safety after marketing approval, highly depends on the adequate reporting of adverse drug reactions (ADRs). To improve pharmacovigilance awareness and future ADR reporting among medical students, we developed and evaluated a student-run pharmacovigilance programme.

methodsIn this project, teams of medical students (first- to fifth-year) assessed real ADR reports, as submitted to the national pharmacovigilance centre. After assessment of causality, including identification of a potential pharmacological explanation for the ADR, the students wrote a personalized feedback letter to the reporter, as well as a summary for the European Medicines Agency (EMA) and World Health Organization (WHO) pharmacovigilance databases. This student assessment was then verified and evaluated by staff from The Netherlands Pharmacovigilance Centre Lareb (Lareb), using an e-questionnaire. Student attitudes, intentions, skills, and knowledge of ADR reporting were evaluated using the e-questionnaire, before and after participation in the programme.

resultsFrom May 2014 to January 2015, a total of 43 students assessed 100 different ADR reports selected by Lareb staff (n = 3). Student assessments were rated as useful (93%), scientifically substantiated (90%), accurate (92%), and complete (92%), and, on average, did not cost Lareb staff extra time. Medical students were positive about ADR reporting, and their awareness of ADR reporting increased significantly following participation in the programme (p < 0.05). After participation in the programme, the students intended to report serious ADRs in their future practice, and their knowledge of pharmacovigilance and ADR reporting showed they had a high overall level of pharmacological understanding.

conclusionThe student-run pharmacovigilance programme is a win-win venture. It offers students a valuable 'pharmacovigilance experience', creates awareness in future doctors, and has the potential to increase pharmacovigilance skills and knowledge.

Indexed as

Adverse Drug Reaction Reporting SystemsPharmacovigilanceStudents, MedicalClinical CompetenceCohort StudiesDrug-Related Side Effects and Adverse ReactionsEducational MeasurementEducation, MedicalHealth Knowledge, Attitudes, PracticeHumansNetherlandsProduct Surveillance, PostmarketingProspective Studies

Identifiers

PMID28120270
PMCPMC5384963

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.